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Clinical and pharmacokinetic phase II study of one hour infusion of kahalalide F administered every week to patients with Non Small Cell Lung Cancer Stage IIIB with pleural effusion and stage IV, after first line chemotherapy

Clinical and pharmacokinetic phase II study of one hour infusion of kahalalide F administered every week to patients with Non Small Cell Lung Cancer Stage IIIB with pleural effusion and stage IV, after first line chemotherapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-001253-29-ES
Enrollment
34
Registered
2004-09-16
Start date
2004-05-13
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer Stage IIIB and IV after first Line Chemotherapy MedDRA version: 5.0 Level: LLT Classification code 10029514

Interventions

Product Name: kahalalide Pharmaceutical Form: Powder and solvent for solution for infusion Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Concentration unit:

Sponsors

PharmaMar SAU
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologically proven diagnosis of Non Small Cell Lung Cancer Stage IIIB with pleural effusion and Stage IV ,with progressive disease within the last four months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Previous Chemotherapy within the last four weeks

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluar la actividad antitumoral de Kahalalide administrado en infusion semanal de una hora a pacientes con cancer de pulmon no microcitico, estadio IIIB con derrame pleural y estado IV , tras una primera linea de quimioterapia.;Secondary Objective: Perfil de toxicidad, evaluacion farmacocinetica.;Primary end point(s): Objective Response (Complete Response and Partial Response)—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026